Clinical trial · Interventional
A Pharmacokinetic Study of Bortezomib in Taiwanese Participants With Multiple Myeloma
Pharmacokinetic Study of Bortezomib (VELCADE) Administered Intravenously in Taiwanese Patients With Multiple Myeloma - A Post Approval Commitment Study
NCT02268890CI-TRIAL-00022934completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the pharmacokinetic (PK-the study of the way a drug enters and leaves the blood and tissues over time) characteristics of bortezomib when administered intravenously in Taiwanese participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib
- description
- Participants will receive a 1.3 milligram per square meter per dose (mg/m\^2/dose) of bortezomib intravenously on Days 1, 4, 8, and 11.
- interventionNames
- Drug: Bortezomib
Primary outcomes (8)
- measure
- Initial Observed Plasma Drug Concentration (Co)
- timeFrame
- 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
- description
- Initial concentration extrapolated to time zero (Co) will be evaluated.
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- 72 hours pre-dose on Day 1 (Baseline); post-dose on Day 11, 12, 13 and 14
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma based on the standard criteria * Measurable, secretory multiple myeloma is defined as serum monoclonal immunoglobulin (Ig) G of \>= 10 gram per liters (g/L), serum monoclonal IgA or IgE greater than or equal to (\>=) 5 g/L, serum monoclonal IgD \>= 0.5 g/L, or serum monoclonal IgM present (regardless of level), or urine M protein of \>= 200 mg/24 hour at any time point of prior treatment * Relapse or progression of myeloma following prior systemic antineoplastic therapy and meet the indication which had been approved in the drug leaflet. Relapse is defined as: a) reappearance of measurable disease (as defined above) following complete response (CR); b) \>= 25 percent (%) increase in serum or urine M-protein according to IMWG (International Myeloma Working group) criteria; c) development of new or worsening lytic bone disease; d) new plasmacytomas or \>=50% increase in the longest dimension of an existing plasmacytoma; e) worsening hypercalcemia (corrected serum calcium \>11.5 milligram per deciliters \[mg/dL-2.8 millimoles per liters \[mmol/L\] due to multiple myeloma * Karnofsky performance status \>=70% * Platelet count \>=50 × 10\^9 /L without transfusion support within 7 days before the laboratory test Exclusion Criteria: * More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a \>6 month treatment-free interval) * Peripheral neuropathy or neuropathic pain of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade \>=2 * Any of the following within 3 weeks prior to enrollment in the study: antineoplastic or experimental therapy, corticosteroid use above 10 mg/day (prednisone or equivalent), or plasmapheresis * Any of the following within 2 weeks prior to enrollment in the study: radiation therapy, major surgery (kyphoplasty is not considered major surgery) * Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
References
Publications (0)
Data not yet available
No reference posted for this study.